MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX 8MM4CM 155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51008004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

This report is related to report #9616099-2022-05768.As reported, two saber pta balloons were for post dilation after a smart (9mmx6cm) stent placement; however, both balloons ruptured during inflation.First balloon used was a saber rx 7mm x 4cm, but after insufficient inflation the second balloon was a saber rx 8mm x 4cm.After both ruptures, a non-cordis balloon was used, and the case was completed.There was no reported injury to the patient.The lesion was in the common iliac artery which had a chronic total occlusion (cto).An unknown guidewire crossed the lesion.A saber pta (3mmx4cm) was used for pre-dilation, prior to stent implantation.Additional information was requested; however, the information was not obtained after multiple attempts.The product was not returned for analysis.A product history record (phr) review of lot 82227229 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the devices were not returned for analysis.The exact causes could not be determined.Vessel characteristics of chronic total occlusion likely contributed to the reported event.A chronically occluded vessel makes crossing into the lesion difficult; damage to balloon material may have occurred in the attempt to cross or during inflation.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device and the reported event.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, two saber pta balloons were for post dilation after a smart (9mmx6cm) stent placement; however, both balloons ruptured during inflation.First balloon used was a saber rx 7mm 4cm, but after insufficient inflation the second balloon was a saber rx 8mm4cm.After both ruptures,, a non-cordis balloon was used and the case was completed.There was no reported injury to the patient.The lesion was in the common iliac artery which had a chronic total occlusion (cto).A unknown guidewire crossed the lesion.A saber pta (3mmx4cm) was used for pre-dilation, prior to stent implantation.The devices will not be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

• Brand Name: SABER RX 8MM4CM 155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14884641
• MDR Text Key: 295159638
• Report Number: 9616099-2022-05769
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075425
• UDI-Public: (01)20705032075425(17)240630(10)82227229
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 51008004L
• Device Catalogue Number: 51008004L
• Device Lot Number: 82227229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (8MM*4CM SENRI, TERUMO); SABER PTA (3MMX4CM); SMART STENT (9MM*6CM); UNK GUIDE WIRE